A Phase II, Open Label, Multi-Dose Study of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) for Positron Emission Tomography (PET/CT) in Patients With Selected Advanced or Metastatic Solid Malignancies Who Are Scheduled to Receive Standard-of-Care Immunotherapy Only, As Single Agent or in Combination

Who is this study for? Adult patients with Advanced or Metastatic Melanoma, Non-Small Cell Lung Cancer, Renal Cell Carcinoma, or Head and Neck Squamous Cell Carcinoma
Status: Completed
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this study is to evaluate the safety of repeat doses ⁸⁹Zr-Df-IAB22M2C and to establish the relationship between ⁸⁹Zr-Df-IAB22M2C PET/CT lesion uptake with CD8+ cells by immunohistochemical staining in patients with selected advanced and metastatic solid malignancies who are scheduled to receive standard of care immunotherapy. The study will also evaluate uptake of ⁸⁹Zr-Df-IAB22M2C by PET/CT in patients at baseline and on immunotherapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

⁃ Participants will be eligible for enrollment in the study only if they meet ALL of the following criteria:

• Patients with advanced or metastatic Melanoma, Non-Small Cell Lung Cancer, Renal Cell Carcinoma or Squamous Cell Carcinoma of the Head and Neck with at least one non-radiated lesion, who are scheduled to begin standard of care immunotherapy.

⁃ • At least 1 non radiated measurable lesion documented on CT/, MRI (per RECIST criteria 1.1) or are FDG avid on FDG-PET within 45 days prior to first 89Zr-Df-IAB22M2C (CD8 PET Tracer) infusion.

⁃ At least 1 non-cutaneous lesion that is accessible, per investigator's assessment, and eligible for biopsy. If only a single RECIST measurable lesion is present, investigator to determine if the tumor biopsy could interfere with RECIST assessments of response.

⁃ Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

⁃ Meeting all clinical safety lab values per institution's standard of care, or Investigator's discretion, for patients receiving cancer treatment.

⁃ Age ≥ 18 years.

⁃ Ability to understand the purposes and risks of the trial and has signed an IRB-approved informed consent form.

⁃ Willingness and ability to comply with all protocol required procedures.

⁃ For men and women of child-producing potential, use of effective double barrier contraceptive methods during the study, up to 30 days after the last administration of the investigational product.

Locations
United States
Alabama
University of Alabama-Birmingham Hospital
Birmingham
Arkansas
CARTI Cancer Center
Little Rock
California
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte
Keck Hospital of USC
Los Angeles
LAC + USC Medical Center
Los Angeles
USC/Norris Comprehensive Cancer Center
Los Angeles
Hoag Memorial Hospital Presbyterian
Newport Beach
John Wayne Cancer Institute at Providence Saint John's Health Center
Santa Monica
Iowa
University of Iowa Hospitals and Clinics
Iowa City
Massachusetts
Dana-Farber Cancer Institute (DFCI)
Boston
Michigan
Karmanos Cancer Institute
Detroit
Missouri
Washington University School of Medicine
Saint Louis
New York
Memorial Sloan Kettering Cancer Center
New York
Pennsylvania
University of Pennsylvania, Perelman School of Medicine
Philadelphia
Washington
Seattle Cancer Care Alliance/ University of Washington
Seattle
Time Frame
Start Date: December 18, 2018
Completion Date: July 18, 2022
Participants
Target number of participants: 52
Treatments
Experimental: ⁸⁹Zr-Df-IAB22M2C Infusion
A dose of 3 mCi (±20%) of ⁸⁹Zr-Df-IAB22M2C between 0.5 mg to 1.5 mg of API will be administered intravenously over 5-10 minutes, within one week prior to the onset of immunotherapy, and 5 to 6 weeks after start of IOT.
Authors
Kewen Jauss, Savita Dandapani, Austin Pantel, Sandeep Laroia, Rhonda Gentry, Przemyslaw Twardowski, Steven O'Day, Patrick Ott, Janet Pollard, Misako Nagasaka, Parren McNeely, Tera Feldman, Jiefu Zheng, Yousef Zakharia, David Bushnell, Trevan Fischer, Michael Graham, Paul Chapman, Maria L Parayno, Maria Gargano, Mohammed Milhem, Jamie Burton, Jedd Wolchok, Yusuf Menda, Thomas Sneed, Alexander Shoushtari, Kamal Patel, Diane Wilder, Jacob Thomas, Ammar Sukari, Lisle Nabell, Brendan O'Shea, Kim A Margolin, Mariann Harrington, Sagus Sampath, Elisabeth Heath, Meredith Davis, Lawrence Flaherty, Dave M Yamauchi, Elizabeth Buchbinder, Tanya B Dorff, Jonathan McConathy, Michael Andrew Postow, Rizwan Haq, Morganna Freeman, Grace Raja, Omer Khalil, Heather Jacene, Michael Farwell, David Hays, Lawrence Mendelsohn, Douglas Adkins, Arya Amini, Erminia Massarelli, Pradeep Bhambhvani, Rohan Garje, Ammar A Chaudhry, Janis O'Malley, Farrokh Dehdashti, Megan Insco, Benjamin Izar, Erik Mittra, Douglas Laux, Mohammad Amarneh, Srinivas Peddi, Hirva Mamdani, Ulka Vaishampayan, Ryan Hall, Russell Pachynski, Amanda Livengood, Balagopalan Nair, Daniel Morgansztern, Sam Galgano, Jennifer Frye, Marty Conry, Margaret Callahan, William Carroll, Jill Gormley, Barry A Siegal, Suzy Lapi, Sharon White, Francisco Robert, Dan Pryma, Gagandeep Choudhary, Helen Kaemmerer, Annick D Van den Abbeele, George Ansstas, Anthony Shields, Eddy Yang, David Liu, Amy Weise, F Stephen Hodi, Stephen F Hodi, Jeffrey YC Wong, Charu Aggarwal
Sponsors
Leads: ImaginAb, Inc.

This content was sourced from clinicaltrials.gov

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